Sr. Manager/Associate Director, Regulatory Affairs

Location
Bothell, WA, United States
Posted
Jun 18, 2018
Ref
1-oyVj7fwD
Hotbed
BioForest
Required Education
Bachelors Degree
Position Type
Full time
Summary:

Reporting to the Senior Director, Regulatory Affairs, the Senior Manager / Associate Director will contribute to the development and execution of a successful IND/CTA strategy to support first in human studies for investigational products and/or support active INDs/CTAs with ongoing clinical studies. The successful candidate will serve as a regulatory contact within an internal matrixed team environment, as well as with health authorities and corporate partners.

Responsibilities:
  • Develop integrated regulatory plans that deliver against strategic objectives, maintain compliance, and protect patients
  • Ensure receipt of timely and actionable health authority feedback around key issues and program milestones, by defining the strategy and content to support agency interactions
  • Function as primary liaison with health authorities, including providing complete and timely responses to health authority requests for information
  • Assess regulatory program risks for likelihood and impact; establish mitigation strategies
  • Oversee the planning and preparation of submissions to regulatory authorities, related to IND/CTA maintenance
  • Advise on regulatory requirements, expected outcomes, and changes to landscape


Qualifications:
  • Bachelor's degree in a life sciences discipline and a minimum of 7 years regulatory experience
  • Oncology experience strongly preferred
  • Knowledge of US regulatory requirements and opportunities for expediting development programs for serious conditions
  • Experience interacting with health authorities
  • Able to manage conflicting priorities and adhere to tight timelines
  • Able to consider and account for multiple options and opinions
  • Able to travel for meetings with corporate partners and regulatory authorities


Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.